AVADEL

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anonymous said:
Interested how they will spin this at the Jefferies Healthcare Conference what’s happening to the sales force?
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The question that the FDA communication did NOT addressed was matters related to the ODE and whether AVDL satisfied (without clear head to head data vs JAZZ oxybates) the "major contribution to patient care". Otherwise, FT218 will only receive a tentative approval, and will not be allowed in the Market in 2023.

Maybe some smart analyst can ask that question.
 




anonymous said:
The question that the FDA communication did NOT addressed was matters related to the ODE and whether AVDL satisfied (without clear head to head data vs JAZZ oxybates) the "major contribution to patient care". Otherwise, FT218 will only receive a tentative approval, and will not be allowed in the Market in 2023.

Maybe some smart analyst can ask that question.
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Why were they given and ODD then? Weren’t the FDA involved in their trial design? For superiority direct h2h is needed only for safety if same doses are used. In this case just the waking up with an alarm is considered disruptive to continuous night sleep? Also the big Cmax sue to the second dose can cause severe issues (safety) if not timed appropriately (too close together). Also many people miss the second dose and have symptoms next day? Many fall related to the waking up for second dose (safety)? All these data (safety) dosing related or falls are in Xyrem dsur? To me it looks they have more than enough from a safety and contribution to patient care?
 




Overall it does look they are ready to fight the 963 patent. These will be invalidated sue to obviousness or not being practiced is what’s the message. Apparently the PTAB invalidated some but didn’t review others. They should expect a resolution of the REMS conflict in august -September and that will most likely speed up the process to market
 




Why were they given and ODD then? Weren’t the FDA involved in their trial design? For superiority direct h2h is needed only for safety if same doses are used. In this case just the waking up with an alarm is considered disruptive to continuous night sleep? Also the big Cmax sue to the second dose can cause severe issues (safety) if not timed appropriately (too close together). Also many people miss the second dose and have symptoms next day? Many fall related to the waking up for second dose (safety)? All these data (safety) dosing related or falls are in Xyrem dsur? To me it looks they have more than enough from a safety and contribution to patient care?
 




anonymous said:
Why were they given and ODD then? Weren’t the FDA involved in their trial design? For superiority direct h2h is needed only for safety if same doses are used. In this case just the waking up with an alarm is considered disruptive to continuous night sleep? Also the big Cmax sue to the second dose can cause severe issues (safety) if not timed appropriately (too close together). Also many people miss the second dose and have symptoms next day? Many fall related to the waking up for second dose (safety)? All these data (safety) dosing related or falls are in Xyrem dsur? To me it looks they have more than enough from a safety and contribution to patient care?
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ODD is granted based on a hypothesis that is then demonstrated in the clinical trials. It is not the FDA's job to tell them what the need to do to obtain ODE. Avadel could have generated the data to prove these theories but Avadel avoided including existing Xyrem patients in their trial because they knew they had a clinically inferior product. There is nothing in the clinical data that indicates the product is safer and not sure doubling bedwetting is a contribution to patient care.
 








Looks like a bunch of biased posts. Clinical superiority was awarded on the plausibility of superiority related to the once nightly dosing. They don’t need to include a Xyrem arm to show that. If a single dose provides the same efficacy then it’s a clinical superior product. Majority of patients have disrupted nightly sleep which is exacerbated by the twice dosing with alarm. Taking two doses close together is dangerous. Also getting up to take the second dose has resulted in falls. Some forget to take the second dose and misplace the dose? Many issues. This is like conversion of a daily dosing to a once a month dose. You don’t need a head to head comparison
 




anonymous said:
ODD is granted based on a hypothesis that is then demonstrated in the clinical trials. It is not the FDA's job to tell them what the need to do to obtain ODE. Avadel could have generated the data to prove these theories but Avadel avoided including existing Xyrem patients in their trial because they knew they had a clinically inferior product. There is nothing in the clinical data that indicates the product is safer and not sure doubling bedwetting is a contribution to patient care.
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Did not include because they knew it’s an inferior product? They do have a restore trial ongoing for that. Have you seen the results? Using an alarm to wake up everybody + falling when waking up to take the second dose + dangerously high Cmax when taking the two doses too close together + lack of efficacy by forgetting to wake up and take second dose + disruptive nightly wake up schedule for life for the patient and all around + leaving a second dose mixed on bed stand which has to be trashed (or stolen by kids)? There does seem some advantages to the once at bedtime formulation?
 
















anonymous said:
Press release on major layoff and restructuring that’s why it’s been quiet with tentative approval 12 months from now a full 18 months later than expected interesting
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Layoffs are the one thing Avadel has been good at. Other than that, they have been wrong at every turn and this announcement is a pathetic last gasp.
 
























anonymous said:
I don’t see any issues they have been ghosted by fda for 8 months and now how a possible tentative approval in June of 2023 don’t see any red flags
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There is one red flag.

The Orphan Office has to approve the Orphan Drug Exclusivity on the basis of a major contribution to patient care and superior to JAZZ's Xyvaw which currently holds the exclusivity.

FDA recognized seven years of Orphan Drug Exclusivity for Xywav in June 2021 for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy, and in December 2021 for the treatment of idiopathic hypersomnia in adults.

AVADEL has not submitted any data on the ongoing to the FDA for review; thus, it will be difficult for the FDA to break JAZZ's exclusivity without head-2-head data. The completion of the study, the submission of additional data and the FDA 6 months review period, will easily add another 2 years of waiting.

Does AVADEL have a different view?
 




There is no red flag

WE ARE AVADEL

WE HAVE BALLS OF STEEL

WE ARE SUING THE FDA
THEIR KNEES WILL BUCKLE
IT WONT BE LONG BEFORE THEY WILL BE GOOD PUPS AND BE LICKING OUR BALLS & BOOTS

APPROVAL COMING SOON
 




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